Senior Supplier Quality Engineer

Senior Supplier Quality Engineer

Location: Draper, UT

Pay: $55.00-$65.00/hour

Duration: 6-Month Initial Contract

Schedule: Standard Office Hours, On-Site




The Senior Supplier Quality Engineer will play a key role in critical projects. This position is cross-functional and requires strong collaboration with R&D, Design Assurance, Operations, Regulatory Affairs, Supplier Development Engineering, and Receiving Inspection. The primary focus is leading successful parts qualification efforts with external suppliers to support product development and commercial launch timelines. The Senior Supplier Quality Engineer will work in a fast-paced, dynamic environment where being proactive and taking initiative are essential to success.

Job Responsibilities

• Lead and perform Gage R&R studies, process capability studies, and supplier process validations related to critical component features based on risks identified in FMEAs.
• Develop and validate test methods, including creating inspection routines for optical measurement equipment and designing inspection fixtures using SolidWorks.
• Provide engineering support to Receiving Inspection for component test methods and investigations.
• Manage supplier-related non-conformances.
• Manage Supplier Corrective Action Requests (SCARs) from initiation through closure.
• Report supplier part qualification status during recurring cross-functional project meetings.
• Collect and analyze Supplier Quality metrics.
• Communicate supplier quality risks to management during management reviews and project meetings and identify solutions to mitigate risks.

Required Skills & Qualifications

• Knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 9001, and other applicable international regulatory standards.
• Experience with Design Controls and test method development and validation.
• Demonstrated experience driving component testing, test method validations, and equipment testing/validation.
• Experience with statistical techniques and tools, including Gage R&R, Statistical Process Control (SPC), and process capability studies.
• Ability to conduct effective root cause analysis, drive non-conformance investigations, and assess corrective action strategies and effectiveness through CAPA processes.
• Knowledge of GD&T and ability to read and interpret engineering drawings.
• Understanding of process validations, including IQ, OQ, and PQ.
• Understanding of manufacturing processes such as injection molding, extrusion, and machining.
• Strong interpersonal and communication skills, with the ability to negotiate and influence change.
• Ability to manage multiple priorities while maintaining a high level of attention to detail.
• Demonstrated ability to achieve results in a cross-functional team environment and build strong relationships with internal and external stakeholders, including suppliers.

Education & Experience

• Bachelor’s degree in Engineering, Science, or a related technical field.
• At least 4 years of engineering experience in a highly regulated industry, such as medical device, aerospace, automotive, or a similar environment.

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